Method and apparatus for template based treatment outcome generation

ABSTRACT

A method for generating a medical report includes receiving patient image data from a user in response to displaying a patient image to the user that is retrieved from a server. The user enters patient image data directly into an image time series template. The patient image data, in one embodiment, pertains to measurements of objects (both target and non-target) of the patient shown in the patient image. Patient image data is then extracted from the image time series template and data is calculated pertaining to an object (e.g., a lesion) in the image based on the extracted data and the location of the extracted data in the image time series template. The calculated results are presented for review by a user. In response to the user approving the results, a report of the results is generated.

FIELD OF THE INVENTION

The present disclosure relates generally to medical image capture, storage and analysis, and more particularly to template based image processing in a clinical setting.

BACKGROUND

Doctors use images of patients in order to diagnose disease, determine disease progression, and determine the effectiveness of treatments such as new treatments used during clinical trials. Over a course of time, images of the same patient (e.g., images of the patient's internal organs) are captured and then stored in a Picture Archiving and Communication System (“PACS”) server. Doctors access images of a particular patient for review and to measure the dimensions of objects, such as lesions. These measurements are then recorded and later used in rule based diagnostics or downstream statistical analysis for clinical trials. Doctors may track the same objects at subsequent points of time to evaluate changes. The measurements within the time series are then evaluated based on different rules and/or criteria to determine if objects have become larger or smaller and allow a doctor to determine the progression of a disease or assess the effectiveness of a treatment. There are protocols such as RECIST and Lugano in oncology. Common clinical trial treatment outcomes are progression, stable, partial response, or complete response. They indicate whether the treatment was non-effective, partially effective, or effective. The information determined using the results of the calculations is often used, particularly in clinical trials, to generate a report regarding treatment effectiveness or disease progression.

Analyzing clinical imaging time series data takes a significant amount of time. Existing radiology reporting software and PACS software do not provide an easy or customizable way to integrate the additional processes for data conversion, standardization, analysis, storage, access and reporting required for in depth studies of these clinical trial imaging data. In the past, oncologists have manually entered data into paper worksheets and used calculators to determine relative change in disease burden and response to therapy. One recent software solution to the aforementioned time-consuming and error-prone manual process of clinical imaging data analysis has been to make modified PACS software that directly export lesion measurements and additional data to an output sheet for further calculation, thereby streamlining diagnosis and the determination of the effectiveness of treatments. However, an important limitation of that approach is that the modified PACS is a stand-alone system which does not directly interface with the standard PACS and voice reporting systems commonly used by radiologists, and thus requires setting up a parallel process in addition to existing clinical read processes. This solution generates inefficiency in terms of new system set up and process duplication for end users.

SUMMARY

A method for generating a medical report includes receiving patient image data from a user in response to displaying a patient image to the user that is retrieved from a server. The user enters patient image data directly into an image time series template. The patient image data, in one embodiment, pertains to measurements of objects (both target and non-target) of the patient shown in the patient image. Patient image data is then extracted from the image time series template and data is calculated pertaining to an object (e.g., a lesion) in the image based on the extracted data and the location of the extracted data in the image time series template. The calculated results are presented for review by a user. In response to the user approving the results, a report of the results is generated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic of a system for generating medical reports and treatment outcomes according to an embodiment;

FIG. 2 shows a typical patient treatment workflow;

FIG. 3 shows a flowchart of a method for generating a medical report according to an embodiment;

FIG. 4 shows a patient treatment workflow according to an embodiment;

FIG. 5 shows a template for receiving information regarding response to a treatment according to an embodiment;

FIG. 6 shows a chart of a response to treatment according to an embodiment; and

FIG. 7 shows a high-level block diagram of a computer according to an embodiment.

DETAILED DESCRIPTION

The method disclosed herein allows radiologists to leverage existing PACS and voice reporting systems and uses templates to convert clinical imaging reports to standardized data compatible with downstream database storage and analysis, thus allowing process integration and automation. The method described herein also represents a modular and minimally invasive way to add on new functionalities to the diverse systems available in the general radiology communities.

FIG. 1 shows system 100 for generating medical reports and determining treatment outcomes (i.e., the result of a treatment for a disease). In one embodiment, the reports and treatment outcomes pertain to clinical trials regarding the effectiveness of a treatment on lesions. Imaging device 102 is configured to capture images of a patient using an imaging technology such as X-ray, computerized tomography, magnetic resonance imaging, etc. Imaging device 102 is in communication with Picture Archiving and Communication System (“PACS”) server 104 which stores images received from imaging device 102. Workstation 106 is in communication with PACS server 104 and can retrieve images from PACS server 104. Workstation 106 can also receive input regarding images retrieved from PACS server 104 and store data and/or user input (e.g., comments and/or notes) pertaining to the retrieved images on PACS server 104. PACS server 104 is also in communication with offsite workstation 112 via network 110 (e.g., the Internet) and firewall 108. Web portal 114 is executed on a computer (not shown) and is also in communication with PACS server 104 via network 110 and firewall 108. Web portal 114 can also communicate with workstation 106 and offsite workstation 112. A user can access images and add comments and/or notes about an image via web portal 114.

FIG. 2 shows a typical prior art patient treatment workflow 200 detailing the capture, storing, and analyzing of images, generation of medical reports, and generation of treatment outcomes. FIG. 2 is arranged to show system components identified by the label system 230 located above output components identified by the label output 240 (i.e., outputs of systems or people) which is shown above people identified by the label people 250. System 230, in one embodiment, includes imaging device 102, PACS server 104, and radiology reporting software 219. Output 240, in one embodiment, includes image 208, report 210, and clinical analysis report 214. People 250, in one embodiment, includes radiologist 209 and radiologist/oncologist 211.

Workflow 200 of FIG. 2 does not use software templates and/or tools to generate medical reports or treatment outcomes. Workflow 200 of FIG. 2 uses manual data compiling, calculation and entry. Although some prior art patient treatment workflows use proprietary commercial software (not shown), the commercial software is a parallel process in addition to regular generation of reports, clinical analysis reports, treatment outcomes, etc.

Clinical research organization 202 and/or health care provider 204 capture image 208 of patient 206 using imaging device 102. The captured image is transmitted from imaging device 102 to PACS server 104 as shown by arrow 207. At PACS server 104, image 208 can be accessed by a user such as radiologist 209. Radiologist 209, in one embodiment, accesses patient images stored in PACS server 104 via one of workstations 106 or 112 (shown in FIG. 1 ). Radiologist 209 dictates report 210 using information shown in the images retrieved from PACS server 104. In one embodiment, radiologist 209 uses radiology reporting software 219 (e.g., voice to text software running on one or more of workstations 106 and 112) in order to dictate report 210 as shown by arrow 216. In one embodiment, radiology reporting software 219 provides prompts for dictation as shown by arrow 221. Radiology reporting software 219 stores report 210 in PACS server 104 as shown by arrow 217. It typically takes radiologist 209 5-15 minutes per time series of a patient (i.e., a series of images of a patient over time, also referred to as a study) to dictate a report. Data from the report is used by a user, such as radiologist/oncologist 211, to perform calculations related to the information in the report. For example, data in the report can pertain to dimensions of lesions and the calculations can relate to a change in size of a lesion. It typically takes 15-45 minutes per study to enter data and perform calculations. Based on the data entered and calculations performed, a treatment outcome based on a time series (also referred to as a clinical analysis report) 214 is determined and entered by the user as shown by arrow 218. The treatment outcome can indicate if a treatment has a beneficial effect on a patient (such as decrease in the size and/or number of lesions). The treatment outcome can identify whether or not a particular treatment is effective. For example, treatment outcome 214 (also referred to as clinical analysis report) can contain one or more identifiers pertaining to an object. The identifiers can comprise terms such as steady disease, progression, partial response or complete response, based on the result of calculations compared to published diagnostic criteria. Steady disease means that the disease has not progressed since last observation. Progression means that disease has worsened since last observation, Partial response means that disease has somewhat improved, for example lesion sizes reduced somewhat since last observation. Complete response indicates that treatment was effective, for example reducing lesion size sufficiently.

The time required to enter the data obtained by analyzing images and to perform the calculations to determine a treatment outcome can be significant. For example, as described above, a user typically spends 15-45 minutes per study to enter the data and perform calculations. One reason that the time required is significant is because for every calculation that needs to be performed, a user has to identify the data required to perform the calculation from all the data that was generated based on one or more images.

The present embodiments solve the problems of the prior art approaches. In one embodiment, the radiologist enters information into a template. The time required for data entry and calculation is reduced significantly by use of the template. FIGS. 3 and 4 show a method according to an embodiment using a template. FIG. 3 shows a flowchart of method 300 for determining a treatment outcome based on images of a patient. FIG. 4 shows a patient treatment workflow 400 according to an embodiment. Similar to FIG. 2 , FIG. 4 is arranged to show system components identified by the label system 430 located above output components identified by the label output 440 (i.e., outputs of systems or people) which is shown above people identified by the label people 450. System 430, in one embodiment, includes imaging device 102, PACS server 104, and radiology reporting software 219, and data entry and calculation server 412. Output 440, in one embodiment, includes image 408, template 500, and clinical analysis report 600. People 450, in one embodiment, includes radiologist 409, radiologist 416, oncologist/provider 418, and administrator 420.

At step 302, a patient is scanned to generate an image. For example, a scan can generate an image of a patient's internal soft tissue such as organs. As shown in FIG. 4 , patient 406 can be scanned by a clinical research organization 402 or healthcare provider 404 using imaging device 102. At step 304, image 408 of patient 406 is stored, in one embodiment, in PACS server 104 as shown in FIG. 4 by arrow 407. At step 306, the image of the patient is displayed to a user, such as radiologist 409. In one embodiment, a user can view the image using a workstation, such as workstation 106 or offsite workstation 112 shown in FIG. 1 . It should be noted that a user can view the image that was captured and stored at any time after the image has been stored. For example, steps 302 and 304 can be completed on a particular date and time and step 306 can occur minutes, hours, days, weeks, etc. after the image has been stored.

Returning to FIG. 3 , at step 308 patient image data is dictated directly into an image series template by a user. This patient image data, in one embodiment, is from radiologist 409 reviewing image 408 of patient 406 and dictating patient image data into image series template 500 as shown by arrow 419 in FIG. 4 . Patient image data, in one embodiment, is dictated to radiology reporting software 219 (e.g., voice to text software) which can provide prompts to a user to dictate information as shown by arrow 421. Dictated patient image data, in one embodiment, is stored in PACS server 104 as shown by arrow 417. In one embodiment, the patient image data pertains to the location and size of objects (e.g., lesions, tumors, and/or masses, etc.) shown in the image. In one embodiment, the patient image data comprises data related to measurement of objects by the user viewing a patient image. The patient image data is entered directly into the image series template using a workstation (e.g., workstation 106 or offsite workstation 112 shown in FIG. 1 ) and stored in PACS server 104. In one embodiment, data being entered directly into the image series template means that the user is entering data (e.g. dictation using voice to text, manual entry, etc.) in specific locations (e.g., fields for receiving data) of the image series template as identified in the image series template. For example, all data pertaining to a particular object is entered in a group of fields identified in the image series template. Each field identifies the data that should be entered in that field (e.g., size of long axis determined by measurement, size of short axis determined by measurement, etc.)

FIG. 5 shows template 500 for receiving information from a user pertaining to an image of a patient. In one embodiment, the template is retrieved from a storage device associated with a workstation (such as one of workstations 106 or 112) and the user reviews the image and enters information pertaining to the image using template 500 via one of the workstations. In one embodiment, the information pertaining to the image is entered into template 500 using radiology reporting software 219 located on one of workstations 106 or 112. In one embodiment, patient and examination information 502 portion of template 500 is configured to receive input from a user identifying a patient (e.g., anonymously identifying using a Subject ID) an identification of a week or cycle of treatment, and identification of an examination type and an examination date (e.g., the date that a related image was captured.) Target lesion 504 portion of template 500 is configured to receive information regarding target lesions. Template 500 can receive information regarding up to five target lesions. For each target lesion, a user can enter the type of the lesion, the anatomic location of the lesion, the size in millimeters of a long axis and a short axis of the lesion, and the series and/or image number of the image being reviewed.

Non-target lesion 506 portion of template 500 is configured to receive information from a user regarding up to three non-target lesions. For each non-target lesion, a user can enter the type of the lesion, the anatomic location of the lesion, the size in millimeters of a long axis and a short axis of the lesion, and the series and/or image number of the image being reviewed.

New lesions 508 portion of template 500 is configured to receive information from a user regarding new lesions that have been identified since a baseline study was conducted. Information regarding up to three new lesions can be entered. For each new lesion, a user can enter the type of the lesion, the anatomic location of the lesion, the size in millimeters of a long axis and a short axis of the lesion, and the series and/or image number of the image being reviewed.

Additional comments 510 portion of template 500 is configured to allow a user to enter comments, such as comments pertaining to study quality limitations, indeterminate lesions to be tracked, etc. In one embodiment, information input into template 500 is stored in a storage device of a workstation, such as workstation 106 or 112.

Returning to FIG. 3 , at step 310, patient image data is extracted from image time series template 500. In one embodiment a workstation (such as one or workstations 106 or 112) retrieves data that was directly entered into one or more fields of the image time series template. In one embodiment, the data that was entered directly into one or more field of the image time series template is retrieved from radiology reporting software 219 as shown by arrow 423. In one embodiment, the data is retrieved from PACS server 104 in order for data entry and calculation server 412 to perform calculations. At step 312, object data pertaining to an object in an image is calculated. In one embodiment, performance of the calculations is facilitated because of template 500. Since information is entered into template 500 in a known location, that information can be used to identify values, such as long axis and short axis values for a lesion, that can then be used to perform calculations. Calculations are performed, as shown in FIG. 4 , at data entry and calculation server 412.

In one embodiment, the calculations performed pertain to changes in the sizes of various lesions. For example, multiple images of a patient captured over time can be used to compare the size of lesions over time and determine if the lesions are growing or shrinking. In one embodiment, additional calculations, such as overall change in lesions, can be calculated as well. Calculations, in one embodiment, are automatically performed (e.g., by a workstation that received input to a template) using information input into template.

Returning to FIG. 3 , at step 314, the result of the calculations are presented to the user. In one embodiment, the results are configured into clinical analysis report 600 and the user can be one or more of radiologist 416, oncologist 418, or administrator 420. In one embodiment, the results are presented to the user on a display via workstation 106 or offsite workstation 112 as shown in FIG. 1 . In one embodiment, the result of the calculations are presented to a user via web portal 114. The results can be presented to a user via other methods such as printouts.

In one embodiment, the results of the calculations of step 312 are presented (in step 314) in a particular format. FIG. 6 shows clinical analysis report 600 (also referred to as a chart) that is configured to contain the results of the calculations of step 312 according to an embodiment. Header 602 identifies the patient to which the report pertains to by the patient's initials and a subject identification number that is assigned to the patient. Response column 604 contains information regarding how tumor and lesions are responding to a particular protocol (i.e., treatment) and information keys for information that can be located in cycle columns 606, 608, and 610. Cycle columns 606, 608 and 610 each contain tumor and lesion information that is derived from a patient image. Response column 604, row 612 pertains to identification of a method of evaluation. For example, in one embodiment, the method of evaluation may be a computed tomography scan or a magnetic resonance imaging scan. Cycle columns 606, 608, and 610 row 612 identify a cycle number and a date pertaining to the associated cycle number.

Response column 604 row 614 shows target lesion measurements for up to five target lesions. Cycle columns 606, 608, and 610 row 614 identify measurements of up to five lesions at the associated date identified in row 612.

Response column 604 row 616 shows a key for identifying a response of target lesions to a treatment. The key indicates that CR means disappearance of all lesions, PR means at least a 30% decrease in the sum of diameters of the lesions, PD means at least a 20% decrease in the sum of diameters of the lesions, and SD means neither PR or PD. Cycle columns 606, 608, and 610 row 616 contain one of the identifiers listed in response column 604 row 616.

Response column 604 row 618 shows non-target lesion measurements for up to five non-target lesions. Cycle columns 606, 608, and 610 row 618 identify measurements of up to five non-target lesions at the associated date identified in row 612.

Response column 604 row 620 shows a key for identifying a response of non-target lesions to a treatment. The key indicates that CR means disappearance of all non-target lesions and normalization of tumor marker level. Non-CR/Non-PD means persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. PD means progression of existing non-target lesions/new lesions. Cycle columns 606, 608, and 610 row 620 contain one of the identifiers listed in response column 604 row 616.

Response column 604 row 622 shows a key identifying an evaluation of best overall response of lesions to a treatment. An overall response is identified depending on the identified response to treatment by the target lesion, the non-target lesions, and the new lesions.

An overall response of CR is used when the target lesions' response is identified as CR, the non-target lesions' response is identified as CR and there are no new lesions. An overall response of PR is used when the target lesions' response is identified as CR, the non-target lesions' response is identified as non-CR/non-PD and there are no new lesions. An overall response of PR is used when the target lesions' response is identified as CR, the non-target lesions' response is identified as not having been evaluated and there are no new lesions. An overall response of PR is used when the target lesions' response is identified as PR, the non-target lesions' response is identified as non-PD or not all evaluated and there are no new lesions. An overall response of SD is used when the target lesions' response is identified as SD, the non-target lesions' response is identified as non-PD or not all evaluated and there are no new lesions. An overall response of PD is used when the target lesions' response is identified as PD, and there are or aren't new lesions. Cycle columns 606, 608, and 610 row 622 identify one of CR, PR, SD, or PD as indicated in the key of response column 604 row 622.

Returning to FIG. 3 , at step 316 a user (e.g., one or more of radiologist 416, oncologist 418, or administrator 420) approves the results of the calculations shown in chart 600 of FIG. 6 as shown by arrow 425 of FIG. 4 . In one embodiment, a report of the results shown in chart 600 is generated at step 316 in response to the user approving the results of the calculations and output as shown by arrow 424 in FIG. 4 . In one embodiment, the report identifies a treatment outcome that occurred in response to a particular treatment. For example, the treatment outcome can indicate the effect of the treatment on both target and non-target lesions. The treatment outcome can also indicate whether new lesions have appeared since a treatment began. In one embodiment, input is received from a user modifying the results based on the user's analysis of the patient image data. The report generated at step 318, in one embodiment, is stored in PACS server 104 and can be accessed by authorized users for review and/or modification.

In one embodiment, the data entry and calculation server can populate some of the fields of template 500. For example, fields in template 500 describing an anatomic location of various target and non-target lesions can be prepopulated based on previously acquired patient data.

Workstation 106, offsite workstation 112, PACS server 104, data entry and calculation server 412, a computer supporting web portal 114, and other devices can be implemented using a computer. A high-level block diagram of such a computer is illustrated in FIG. 7 . Computer 702 contains a processor 704 which controls the overall operation of the computer 702 by executing computer program instructions which define such operation. The computer program instructions may be stored in a storage device 712, or other computer readable medium (e.g., magnetic disk, CD ROM, etc.), and loaded into memory 710 when execution of the computer program instructions is desired. Thus, the method steps of FIG. 3 can be defined by the computer program instructions stored in the memory 710 and/or storage 712 and controlled by the processor 704 executing the computer program instructions. For example, the computer program instructions can be implemented as computer executable code programmed by one skilled in the art to perform an algorithm defined by the method steps of FIG. 3 . Accordingly, by executing the computer program instructions, the processor 704 executes an algorithm defined by the method steps of FIG. 3 . The computer 702 also includes one or more network interfaces 706 for communicating with other devices via a network. The computer 702 also includes input/output devices 708 that enable user interaction with the computer 702 (e.g., display, keyboard, mouse, speakers, buttons, etc.) One skilled in the art will recognize that an implementation of an actual computer could contain other components as well, and that FIG. 7 is a high level representation of some of the components of such a computer for illustrative purposes.

The foregoing Detailed Description is to be understood as being in every respect illustrative and exemplary, but not restrictive, and the scope of the inventive concept disclosed herein is not to be determined from the Detailed Description, but rather from the claims as interpreted according to the full breadth permitted by the patent laws. It is to be understood that the embodiments shown and described herein are only illustrative of the principles of the inventive concept and that various modifications may be implemented by those skilled in the art without departing from the scope and spirit of the inventive concept. Those skilled in the art could implement various other feature combinations without departing from the scope and spirit of the inventive concept. 

The invention claimed is:
 1. A method comprising: receiving patient image data from a user directly into an image time series template configured to receive the patient image data in known locations, each of the known locations corresponding to specific kinds of values of the patient image data, the patient image data pertaining to measurement of an object shown in a patient image, wherein the object shown in the patient image pertains to one of a target object, a non-target object, and a new object shown in a particular location of the patient image; extracting, based on the known locations, the patient image data from the image time series template; calculating object data pertaining to the object shown in the patient image based on the extracted patient image data and the known locations of the extracted patient image data in the image time series template, the object data comprising a change in the object, wherein the object data comprising a change in the target object and the non-target object and measurement data; presenting results in a first report that are based on the calculated object data, wherein the results comprise a target object response identifying an associated target object's response to a treatment, and the target object response comprises an identifier corresponding to a change in dimensions of the target object; receiving input from a user in response to the presenting; and generating a second report in response to the input from the user, wherein the second report is an approved clinical analysis report identifying a treatment outcome.
 2. The method of claim 1, wherein the measurement of the object comprises measurement of a long axis and a short axis of the object.
 3. The method of claim 2, wherein the object is one of a lesion, a mass, or a tumor.
 4. The method of claim 1, wherein the input from the user modifies the results based on the user's analysis of the patient image data.
 5. The method of claim 1, wherein the input from the user indicates that the user approves the results.
 6. An apparatus comprising: a processor; and a memory to store computer program instructions, which, when executed by the processor cause the processor to perform operations comprising: receiving patient image data from a user directly into an image time series template configured to receive the patient image data in known locations, each of the known locations corresponding to specific kinds of values of the patient image data, the patient image data pertaining to measurement of an object shown in a patient image, wherein the object shown in the patient image pertains to one of a target object, a non-target object, and a new object shown in a particular location of the patient image; extracting, based on the known locations, the patient image data from the image time series template; calculating object data pertaining to the object shown in the patient image based on the extracted patient image data and the known locations of the extracted patient image data in the image time series template, the object data comprising a change in the object, wherein the object data comprising a change in the target object and the non-target object and measurement data; presenting results in a first report that are based on the calculated object data, wherein the results comprise a target object response identifying an associated target object's response to a treatment, and the target object response comprises an identifier corresponding to a change in dimensions of the target object; receiving input from a user in response to the presenting; and generating a second report in response to the input from the user, wherein the second report is an approved clinical analysis report identifying a treatment outcome.
 7. The apparatus of claim 6, wherein the measurement of the object comprises measurement of a long axis and a short axis of the object.
 8. The apparatus of claim 7, wherein the object is one of a lesion, a mass, or a tumor.
 9. The apparatus of claim 6, wherein the input from the user modifies the results based on the user's analysis of the patient image data.
 10. The apparatus of claim 6, wherein the input from the user indicates that the user approves the results.
 11. A non-transitory computer readable medium storing computer program instructions, which, when executed on a processor cause the processor to perform operations comprising: receiving patient image data from a user directly into an image time series template configured to receive the patient image data in known locations, each of the known locations corresponding to specific kinds of values of the patient image data, the patient image data pertaining to measurement of an object shown in a patient image, wherein the object shown in the patient image pertains to one of a target object, a non-target object, and a new object shown in a particular location of the patient image; extracting, based on the known locations, the patient image data from the image time series template; calculating object data pertaining to the object shown in the patient image based on the extracted patient image data and the known locations of the extracted patient image data in the image time series template, the object data comprising a change in the object, wherein the object data comprising a change in the target object and the non-target object and measurement data; presenting results in a first report that are based on the calculated object data, wherein the results comprise a target object response identifying an associated target object's response to a treatment, and the target object response comprises an identifier corresponding to a change in dimensions of the target object; receiving input from a user in response to the presenting; and generating a second report in response to the input from the user, wherein the second report is an approved clinical analysis report identifying a treatment outcome.
 12. The non-transitory computer readable medium of claim 11, wherein the measurement of the object comprises measurement of a long axis and a short axis of the object.
 13. The non-transitory computer readable medium of claim 12, wherein the object is one of a lesion, a mass, or a tumor.
 14. The non-transitory computer readable medium of claim 11, wherein the input from the user modifies the results based on the user's analysis of the patient image data.
 15. The non-transitory computer readable medium of claim 11, the operations further comprising: receiving input from the user approving the results. 